The sBLA submission included results from the randomized, parallel-arm, placebo-controlled and active-controlled trial foresiGHt.
Compared with placebo, obicetrapib lowered LDL-C by 33% at day 84 ( P <.0001). Changes in other biomarkers, including high-density lipoprotein cholesterol (HDL-C), non-HDL-C, lipoprotein (a), ...
Number of people with at least one episode of HSV-attributable genital ulcer disease was 187.9 and 16.7 million for HSV-2, HSV-1 in 2020 ...
The FDA is expected to decide on treatments for EBV-positive posttransplant lymphoproliferative disease, breast cancer, Barth syndrome, pain, and migraine.
Findings seen among children and adolescents with type 1 diabetes and nonoptimal control with traditional treatment ...
A higher risk of liver transplant and death was observed in Ocaliva-treated patients vs those who received placebo.
A Prescription Drug User Fee Act target date of July 24, 2025 has been set for the sNDA application. The Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) ...
(HealthDay News) — Adults receiving chiropractic spinal manipulative therapy (SMT) for tension-type headache have a significantly lower likelihood of butalbital prescription, according to a study ...
The burden of respiratory syncytial virus (RSV) in young children continues to be high in the United States, according to a study published online Dec. 9 in JAMA Pediatrics. Heidi L. Moline, MD, MPH, ...
SER-155 is an oral, 16-strain microbiome therapeutic that works by decolonizing gastrointestinal pathogens, strengthening the epithelial barrier, and inducing immune tolerance.
Interim data from a phase 3 study evaluating tecovirimat for the treatment of human mpox virus showed the antiviral did not improve time to lesion resolution compared with placebo.
Screening recommended every three years with cervical cytology for women aged 21 to 29 years, every five years with hrHPV screening at age 30 to 65 years ...